Magnetic Resonance Imaging (MRI) Study of the Hippocampus... | NCT00867581

Studies
Magnetic Resonance Imaging (MRI) Study of the Hippocampus After Infarction in the Territory of the Middle Cerebral Artery

NCT00867581

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Mar 24, 2009Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jul 2009Estimated

Completion Date

Not provided

First Submitted Date

Mar 23, 2009

First Submission Date that Met QC Criteria

Mar 23, 2009

First Posted Date

Mar 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2009

Last Update Posted Date

Mar 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to observe delayed neuronal death of hippocampus after middle cerebral artery infarction in human beings.

Detailed Description

40 patients with middle cerebral artery infarction and 40 healthy volunteers will be observed. All of them will receive MRI scan and the assessment of the neuropsychological function (MMSE, AVLT, HAMD) intending to observe delayed neuronal death of hippocampus after middle cerebral artery infarction in human beings.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		chronic-stage patients after infarction in the territory of unilateral middle cerebral artery
2		age, sex and risk factor matched volunteers without ischemic stroke

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of middle cerebral artery infarction
At least six months from the stroke
Must be able to measure his(her) neuropsychologic function (by MMSE, AVLT)

Exclusion Criteria:

Unable to undergo examinations due to disturbances of consciousness or medical conditions
Severe dementia, apraxia, disturbances of sensation or perception
Serious complications including severe heart failure, hepatic dysfunction, renal insufficiency,or shock
Parkinson's disease, malignant tumor, autoimmune diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

chronic-stage patients of unilateral middle cerebral artery infarction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Wang, Doctor	Contact	86-027-8366-3648		wwang_tjh@126.com

Overall Officials

Name	Affiliation	Role
Wei Wang, Doctor	Tongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei		China

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D007238	Infarction

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided